Dolutegravir/lamivudine/tenofovir

Dolutegravir/lamivudine/tenofovir
Combination of
DolutegravirIntegrase strand transfer inhibitor
LamivudineNucleoside reverse transcriptase inhibitor
Tenofovir disoproxilNucleoside reverse transcriptase inhibitor
Names
Other namesTenofovir/lamivudine/dolutegravir (TLD)
Clinical data
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Defined daily dosenot established[1]

Dolutegravir/lamivudine/tenofovir (DTG/3TC/TDF) is a fixed-dose combination medication used to treat HIV/AIDS.[2] It is a combination of dolutegravir, lamivudine, and tenofovir disoproxil.[2] As of 2019, it is listed by the World Health Organization (WHO) as the first line treatment for adults, with tenofovir/lamivudine/efavirenz as an alternative.[3] It is taken by mouth.[4]

Side effects may include trouble sleeping, weight gain, and rash.[3][4] While there are concerns that use during pregnancy results in a 0.2% increased risk of neural tube defects in the baby, this does not rule out its use.[3] Use remains recommended after the first trimester.[3] Use is not recommended in those with kidney problems.[4] The combination is a type of antiretroviral therapy.[3]

It is on the World Health Organization's List of Essential Medicines.[5] In some countries it is available as a generic medication.[6] In the developing world it costs about US$75 per year.[7] It is tentatively approved in the United States as of 2019, full approval is pending expiration of the US patents on dolutegravir (Tivicay) and tenofovir disoproxil (Viread).[8][9] In the United States, a course of treatment costs about $27,600 as of 2019.[10] This amount in the United Kingdom costs the NHS about £26,000 as of 2018.[11]

Medical uses

As of 2019, it is listed by the World Health Organization (WHO) as the first line treatment for adults with HIV/AIDS, with tenofovir/lamivudine/efavirenz as an alternative.[3] It may be used in people with both HIV and tuberculosis, however if the person is on rifampicin a larger dose of dolutegravir is needed.[3]

Dosage

The defined daily dose is not established[1]

Side effects

Side effects may include trouble sleeping and weight gain.[3] While there are concerns that use during pregnancy results in a 0.2% increased risk of neural tube defects in the baby, this does not rule out its use.[3] Use remains recommended after the first trimester.[3] It should not be used with dofetilide.[4]

Cost

In the developing world it costs about US$75 per year.[7] It is considered more cost effective than tenofovir/lamivudine/efavirenz as of 2019.[3]

References

  1. 1 2 "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 1 July 2021. Retrieved 10 September 2020.
  2. 1 2 "Dolutegravir (DTG) and the fixed dose combination (FDC) of tenofovir/lamivudine/dolutegravir (TLD)" (PDF). World Health Organization (WHO). Archived (PDF) from the original on 16 May 2020. Retrieved 15 November 2019.
  3. 1 2 3 4 5 6 7 8 9 10 11 World Health Organization (2019). "Policy brief: update of recommendations on first- and second-line antiretroviral regimens". World Health Organization. hdl:10665/325892. WHO/CDS/HIV/19.15; License: CC BY-NC-SA 3.0 IGO. {{cite journal}}: Cite journal requires |journal= (help)
  4. 1 2 3 4 "WHO-PQ Recommended summary of product characteristics" (PDF). July 2019. Archived (PDF) from the original on 16 November 2019. Retrieved 16 November 2019.
  5. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  6. ↑ "TDF/3TC/DTG" (PDF). Archived (PDF) from the original on 16 November 2019. Retrieved 16 November 2019.
  7. 1 2 Vitoria, M; Hill, A; Ford, N; Doherty, M; Clayden, P; Venter, F; Ripin, D; Flexner, C; Domanico, PL (31 July 2018). "The transition to dolutegravir and other new antiretrovirals in low-income and middle-income countries: what are the issues?". AIDS. 32 (12): 1551–61. doi:10.1097/QAD.0000000000001845. PMID 29746295.
  8. ↑ "NDA 209618 Tentative Approval" (PDF). U.S. Food and Drug Administration (FDA). 25 March 2019. Archived (PDF) from the original on 17 May 2020. Retrieved 16 November 2019.
  9. ↑ "NDA 210796 Tentative Approval" (PDF). U.S. Food and Drug Administration (FDA). 18 August 2017. Archived (PDF) from the original on 17 May 2020. Retrieved 26 March 2020.
  10. ↑ "Mavyret Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 2020-08-01. Retrieved 2020-08-08.
  11. ↑ British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 620. ISBN 9780857113382.
Identifiers:
  • "Dolutegravir". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-05-19. Retrieved 2020-03-26.
  • "Lamivudine". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2020-04-17. Retrieved 2020-03-26.
  • "Tenofovir disoproxil". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2020-01-25. Retrieved 2020-08-03.
  • "Tenofovir disoproxil fumarate". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2019-06-28. Retrieved 2020-03-26.
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